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Research Potential ‘Casualty’ of Trump’s Budget, Sen. Markey Says

Biomedical breakthroughs could become a “casualty” of President Donald Trump’s plan
to boost defense spending by $54 billion, Sen. Edward J. Markey (D-Mass.) said at
a personalized medicine briefing.

“You have to ask yourself, ‘What is the real fear that people have?’ Is it a terrorist
in Fallujah or Mosul?” Markey asked, naming cities in Iraq. “Or is it the terror of
a phone call that another member of your family has that disease?”

The Massachusetts senator, who said his state receives more research dollars per capita
from the National Institutes of Health than any other state, made the case for maintaining
research funding and other social programs one day after Republicans released their
plan to replace the Affordable Care Act. While health-care reform has divided Republicans
and Democrats, members of both parties support funding for medical research.

Critical Juncture

“In 2017, we’re at a critical juncture as we debate the future of health care in this
country,” Markey said of how to ensure people are getting care they need and can afford.

Edward Abrahams, president of the
Personalized Medicine Coalition, said by tailoring treatments to the individual, precision medicine will make health-care
delivery more efficient and therefore less expensive.The coalition hosted the
briefing to draw attention to precision medicine, an emerging approach for disease treatment
and prevention that seeks to maximize effectiveness by taking into account individual
differences and lifestyle, environment and genes. The bipartisan 21st Century Cures
law (
Pub. L. 114-255) to promote medical innovation provided funding for precision medicine, but that
funding must be reauthorized every year.

A
report from the coalition found a growing market for personalized medicines, citing a 62
percent increase since 2012 in the number of them on the market.

Good Business Model

Stephen L. Eck, vice president of oncology medical sciences,
Astellas Pharma Global Development, also said the drug industry as a whole has moved toward developing drugs for specialized
populations.

“We can become more efficient in developing drugs,” he said, adding personalized medicine
is a good business model because “we can deliver a product that’s of much higher value
in a much shorter period of time.”

At the same time, the coalition’s report found that uncertainty in the future of regulation,
such as whether the Food and Drug Administration will regulate laboratory-developed
tests, is discouraging investment in innovative molecular diagnostics.

The FDA issued draft guidance in 2014 proposing to regulate these tests but ultimately
decided not to finalize the document amid disagreements between clinical laboratories
and the device industry. Diagnostics are critical to precision medicine because doctors
use the tools to determine whether a patient will benefit from a specific treatment.

Medical Research Hearing

The briefing occurred in a Senate office building one day before the Senate Appropriations
Committee planned to hold a
hearing on medical research.

While there are no funding details available for fiscal year 2018, the president has
said he wants to boost federal defense spending by $54 million by cutting discretionary
spending, which includes the NIH budget.

“Some things become casualties because you’ve drained so many of your revenues,” Markey
said.

If the NIH experienced a funding cut, it would occur just after the Cures law expressly
provided money for the agency. It would also come right after the NIH saw a $2 billion
increase in 2016, the largest increase in a dozen years. That boost started to reverse
a 22 percent decrease in purchasing power and brought the NIH’s annual budget up to
$32 billion. Senate appropriators approved another $2 billion increase for the agency
last summer, but Congress stopped work on its spending plan for FY 2017 to allow Trump
to weigh in on spending.

“If they have massive tax cuts plus a massive defense spending increase plus a massive
wall [on the U.S.-Mexico border]—and they continue to say they want to balance the
budget— well, something has to go,” Markey told Bloomberg BNA after his remarks. “You
don’t have to be a genius detective to figure out what’s left.”

The nation should be aspiring to lead medical breakthroughs, he said, through robust
NIH funding.

“Medical research is the field of dreams, from which we harvest the findings that
give hopes to families,” Markey said.

To contact the reporter on this story: Jeannie Baumann in Washington at
jbaumann@bna.com

To contact the editor responsible for this story: Randy Kubetin at
RKubetin@bna.com

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